Metformin

Generic Name: Metformin

Brand Names: Actoplus Met, Avandamet, Fortamet, Glucophage, Glucovance, Glumetza, Glycon, Invokamet, Janumet, Jentadueto, Kazano, Kombiglyze, Komboglyze, Qternmet, Riomet, Segluromet, Synjardy, Trijardy, Velmetia, Xigduo

Drug Type: Small Molecule

Chemical Formula: C_₄H_₁₁N_₅

CAS Number: 657-24-9

Unique Ingredient Identifier: 9100L32L2N

Background: Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes.

Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. It is commonly described as an "insulin sensitizer", leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels. Another well-known benefit of this drug is modest weight loss, making it an effective choice for obese patients type II diabetes.

Metformin was first approved in Canada in 1972, and received subsequent FDA approval in the US in 1995.

Indication: Metformin immediate-release formulations

Metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients ≥10 years old with type 2 diabetes mellitus.

Metformin extended-release tablet (XR)

The extended-release formulation of metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Safety in children has not been determined to this date.

Metformin combination products

Metformin is a component of a variety of combination products with other anti-diabetic agents. It is indicated, along with diet and exercise, to improve glycemic control in adult patients with type 2 diabetes mellitus in combination with DPP-4 inhibitors (sitagliptin, linagliptin, alogliptin, or saxagliptin), in combination with SGLT2 inhibitors (canagliflozin, empagliflozin, ertugliflozin, or dapagliflozin), or in combination with pioglitazone.

Associated Conditions: Cardiovascular Mortality, End Stage Renal Disease (ESRD), Hospitalizations, Polycystic Ovarian Syndrome (PCOS), Type 2 Diabetes Mellitus, Decreased estimated glomerular filtration rate

Associated Therapies: -

Clinical Trials

Adding MAraViroc &/or METformin for Hepatic Steatosis in People Living With HIV

Phase 2

Completed

Conditions: HIV-1-infection
Hepatic Steatosis

Interventions: Drug: Maraviroc
Drug: Metformin

First Posted Date: 2017-04-26

Last Posted Date: 2021-11-04

Lead Sponsor: University College, London

Target Recruit Count: 90

Registration Number: NCT03129113

Locations: 🇬🇧
King's College Hospital, London, United Kingdom
🇬🇧
Royal Free Hospital, London, United Kingdom
🇬🇧
Royal London Hospital, London, United Kingdom

and more 3 locations

Metformin Reduce the Relapse Rate on Patients With B-cell Precursor (Ph+ Negative) Acute Lymphoblastic Leukemia

Not Applicable

Completed

Conditions: Acute Lymphoblastic Leukemia

Interventions: Drug: Metformin

First Posted Date: 2017-04-18

Last Posted Date: 2017-07-06

Lead Sponsor: Hospital General de Mexico

Target Recruit Count: 102

Registration Number: NCT03118128

Treatment With Metformin and Combination of Metformin and Pioglitazone in Polycystic Ovarian Syndrome

Early Phase 1

Completed

Conditions: Polycystic Ovarian Syndrome

Interventions: Drug: Metformin, Pioglitazone
Drug: Metformin

First Posted Date: 2017-04-18

Last Posted Date: 2020-03-02

Lead Sponsor: Khyber Medical University Peshawar

Target Recruit Count: 106

Registration Number: NCT03117517

Locations: 🇵🇰
Mardan Medical Complex, Mardan, Khyber Pukhtunkhwah, Pakistan

A Study to Evaluate the Renal Protective Effect (Urine Albumin-to-Creatinine Ratio (UACR)), Efficacy and Safety of Ipragliflozin in Type 2 Diabetes Mellitus Patients With Albuminuria

Phase 4

Terminated

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: metformin
Drug: ipragliflozin
Drug: glimepiride

First Posted Date: 2017-04-18

Last Posted Date: 2024-11-08

Lead Sponsor: Astellas Pharma Korea, Inc.

Target Recruit Count: 33

Registration Number: NCT03118713

Locations: 🇰🇷
Site 11, Guri-si, Korea, Republic of
🇰🇷
Site 01, Seoul, Korea, Republic of
🇰🇷
Site 09, Seoul, Korea, Republic of

and more 5 locations

Metformin Hydrochloride in Mitigating Side Effects of Radioactive Iodine Treatment in Patients With Differentiated Thyroid Cancer

Phase 2

Completed

Conditions: Thyroid

Interventions: Other: Radioactive Iodine
Drug: Metformin Hydrochloride
Other: Placebo

First Posted Date: 2017-04-12

Last Posted Date: 2022-12-15

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 13

Registration Number: NCT03109847

Locations: 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Metformin Hydrochloride in Affecting Cytokines and Exosomes in Patients With Head and Neck Cancer

Early Phase 1

Completed

Conditions: Larynx
Lip
Oral Cavity
Pharynx

Interventions: Radiation: External Beam Radiation Therapy
Other: Placebo
Drug: Metformin Hydrochloride

First Posted Date: 2017-04-12

Last Posted Date: 2020-12-29

Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University

Target Recruit Count: 9

Registration Number: NCT03109873

Locations: 🇺🇸
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus

Not Applicable

Completed

Conditions: Gestational Diabetes Mellitus in Pregnancy

Interventions: Drug: Insulin Mixtard
Drug: Metformin

First Posted Date: 2017-04-11

Last Posted Date: 2017-06-14

Lead Sponsor: Ain Shams University

Target Recruit Count: 62

Registration Number: NCT03106870

Metformin in Intracytoplasmic Sperm Injection Cycles

Phase 2

Completed

Conditions: Intracytoplasmatic Sperm Injection

Interventions: Other: Placebo
Drug: Metformin

First Posted Date: 2017-03-23

Last Posted Date: 2019-09-17

Lead Sponsor: Assiut University

Target Recruit Count: 320

Registration Number: NCT03088631

Locations: 🇪🇬
Women Health Hospital - Assiut university, Assiut, Egypt

Efficacy and Safety of Gosogliptin as Monotherapy and in Combination With Metformin vs. Vildagliptin as Monotherapy and in Combination With Metformin in Drug-naive Type 2 Diabetic Patients.

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Gosogliptin
Drug: Vildagliptin
Drug: Metformin

First Posted Date: 2017-03-23

Last Posted Date: 2017-03-23

Lead Sponsor: SatRx LLC

Target Recruit Count: 299

Registration Number: NCT03088670

Locations: 🇷🇺
State Budget Educational Institution higher professional education "Saratov State Medical University n.a. V.I. Razumovsky" of the Ministry of Healthcare of Russian Federation based on Clinical Hospital n.a S.R. Mirotvortsev, Saratov, Russian Federation
🇷🇺
State Educational Institution of Higher Professional Education "Perm State Medical Academy n.a. academician EA Wagner's "Ministry of Health of the Russian Federation on the basis of Department of Endocrinology Regional Clinical Hospital, Perm, Russian Federation
🇷🇺
State Health Care Institution Leningrad Regional Hospital, Saint Petersburg, Russian Federation

and more 24 locations

Study to Assess the Effect of Metformin Supplementation on IVF Outcome in Patients With Polycystic Ovarian Syndrome.

Phase 3

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Metformin

First Posted Date: 2017-03-22

Last Posted Date: 2017-05-11

Lead Sponsor: Chung-Hoon Kim

Target Recruit Count: 24

Registration Number: NCT03086005

Locations: 🇰🇷
Asan Medical Center, Seoul, Songpa-gu, Korea, Republic of

Drug Development Updates

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